Safety of Treatment of Shoulder Repair

Completed

• Conditions: Rotator Cuff
• Interventions: Device: HEALICOIL Knotless REGENESORB; Device: HEALICOIL Knotless PEEK

• Registration Number: NCT04552119
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair

Detailed Description

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with rotator cuff tendon repair. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-17
• Study Start: 2020-12-30
• Primary Completion: 2024-08-31
• Status Verified: 2024-11
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Requires reattachment of soft tissue to bone for the following shoulder indications:

   1. Rotator Cuff Tendon repair

      • i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
      • ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral row (existing HEALICOIL RG device to be used in medial row of the repair); AND/OR

   2. Biceps tenodesis

      • i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST or HEALICOIL Knotless RG Self-Tapping OR
      • ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not HEALICOIL Knotless RG NST

2. Has a pre-operative standard of care MRI within 6 months of surgery containing the following sequences:

   1. Sat T2 FS: Oblique Sag T2-weighted Fat Saturation Spin Echo (oriented perpendicular to the scapula), with TE > 70 ms, AND
   2. Cor T2 FS: Oblique Cor T2-weighted Fat Saturation Spin Echo (oriented parallel to the scapula), with TE > 70 ms, AND
   3. Sag T1: Oblique Sag T1-weighted Spin Echo (oriented perpendicular to the scapula); OR
   4. Willing and able to undergo an additional study specific pre-operative MRI according to the study Imaging Protocol if the above criteria is not met OR
   5. MRI not required; subject not in HEALICOIL RG NST subgroup

3. Has consented to participate in the study by signing the IRB/IEC approved informed consent form.

4. Requires only one variant of the HEALICOIL Knotless Suture Anchor

5. Is ≥18 years of age at time of surgery

6. Willing and able to make all required study visits

7. Able to follow instructions (Approved translated documents supplied upon request)

Exclusion Criteria

• Any one (1) of the following criteria will disqualify a potential subject from participation in the study:

  1. Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
  2. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
  3. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
  4. Comminuted bone surface, which would compromise secure anchor fixation.
  5. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing
  6. The presence of infection.
  7. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
  8. Concurrent bilateral surgery.
  9. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
  10. Women who are pregnant.
  11. Prior ipsilateral surgeries performed on the joint space.
  12. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HEALICOIL Knotless Suture REGENESORB	HEALICOIL Knotless REGENESORB	HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB
HEALICOIL Knotless PEEK	HEALICOIL Knotless PEEK	HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK

Primary Outcome Measures

Name	Time	Method
Repair failure rate of HEALICOIL Knotless Suture Anchors	6 months	Repair failure rate defined as the need for a second repair procedure at 6 months.

Secondary Outcome Measures

Name	Time	Method
Repair failure rate at 12 months and 24 months	12 and 24 months	Repair failure rate is defined as the need for a second repair procedure. Repair rate at 24 months will be collected for the HEALICOIL Knotless REGENESORB Non-Self Tapping subgroup only.
Single Assessment Numeric Evaluation (SANE) Shoulder scale at 6 months and 12 months	6 and 12 months	The SANE is a simple, single-question, patient-based shoulder function assessment tool: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
Constant-Murley Score	6, 12, and 24 months	Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the subject; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
EQ-5D-3L at 6 months and 12 months	6 and 12 months	The EuroQol EQ-5D-3L is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L dimension.
Tendon thickening and anchor absorption/replacement by bone at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping	6 and 24 months	Magnetic Resonance Imaging (MRI) will be used to determine tendon thickening and anchor absorption/replacement by bone at 6 and 24 months.
American Shoulder and Elbow Surgeons (ASES) Visual Analog Scale (VAS) pain score	6, 12, and 24 months	The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating with a higher score indicating improvement in pain and function. It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs).
Tendon re-tear rate at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping only	6 and 24 months	Magnetic Resonance Imaging (MRI) will be used to determine tendon re-tear rate at 6 months and 24 months.

Trial Locations

Locations (5)

Orthopaedic and Spine Center of Southern Colorado; 🇺🇸 Colorado Springs, Colorado, United States

University of Stanford; 🇺🇸 Redwood City, California, United States

University Orthopedics Center; 🇺🇸 Altoona, Pennsylvania, United States

OrthoIllinois LTD; 🇺🇸 Rockford, Illinois, United States

University of Colorado - Denver; 🇺🇸 Denver, Colorado, United States